DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I (composition) and the species for composition of: biofilm neutralizers: sugar alcohol of xylitol; Antifungals: sea salt, tea tree oil, grapefruit seed extract, colloidal silver; Skin soothing agents: aloe vera, methylsulfonylmethane, essential oil, allantoin; Miscellaneous ingredients: purified water in the reply filed on 01/05/2026 is acknowledged. Applicants withdrew claim 7 which is allantoin, however the species election sets forth an election to allantoin.
Claim 11 and 20-21 are currently withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim because the claims recite non-elected species (i.e. niacinamide, hyaluronic acid and urea). Election was made without traverse in the reply filed on 01/05/2026.
Claims 1-10 and 12-18 are under current examination to the extent of the elected species of a composition comprising the following ingredients: biofilm neutralizers: sugar alcohol of xylitol; Antifungals: sea salt, tea tree oil, grapefruit seed extract, colloidal silver; Skin soothing agents: aloe vera, methylsulfonylmethane, essential oil, allantoin; Miscellaneous ingredients: and purified water.
Information Disclosure Statement
The listing of references on the EFS Acknowledgments Receipt filed 10/3/2023 is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
For a proper information disclosure statement please see 37 CFR 1.98(a)(1) which requires the following: (1) a list of all patents, publications, applications, or other information submitted for consideration by the Office; (2) U.S. patents and U.S. patent application publications listed in a section separately from citations of other documents; (3) the application number of the application in which the information disclosure statement is being submitted on each page of the list; (4) a column that provides a blank space next to each document to be considered, for the examiner’s initials; and (5) a heading that clearly indicates that the list is an information disclosure statement.
Claim Objections
For grammatical completeness of the claim, claim 7 should recite allantoin with a lowercase a and not a capital A.
For grammatical completeness of the claim, claim 9 should recite a composition for treating skin of a patient. The recitation of “treatment” in the claim after patient is considered superfluous.
Claim Rejections - 35 USC § 112(d)-failure to further limit
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 4 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 4 depends from claim 1 and recites “ wherein the antifungal further includes at least one grapefruit seed extract, sea salt, tea tree oil and colloidal silver”. However, claim 1 already requires a grapefruit seed extract, therefore the selection of at least one which includes grapefruit seed extract does not further limit the claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-10 and 12-18 are rejected under 35 U.S.C. 103 as being unpatentable over Scholz et al. (United States Patent Publication 20180207122) in view of Bhushan et al. (United States Patent Publication 2017/0215417), DiLeva (United States 7691419) and Garrett (United States Patent 9511034).
Claim interpretation: The instant claims are being examined to the extent of the elected species to a composition which comprises the following ingredients together: biofilm neutralizers: sugar alcohol of xylitol; Antifungals: sea salt, tea tree oil, grapefruit seed extract, colloidal silver; Skin soothing agents: aloe vera, methylsulfonylmethane, essential oil, allantoin; Miscellaneous ingredients: and purified water.
Claim 1 recites a composition for treating skin of a patient, the composition comprising: a biofilm neutralizer including a sugar alcohol; an antifungal including grapefruit seed extract; and skin soother including aloe vera and an oil, the oil only having a fatty acid chain length of less than C12 or greater than C24.The essential oil of claim 1 having C12 or less is being interpreted as the elected tea tree oil which does not contain any fatty acid chain length. The recitation of a fatty acid chain length of less than C12 is inclusive of essential oils that do not contain any fatty acid chains. Applicants elected a further essential oil to be part of the composition which as evidenced by the specification at page 11 is inclusive of rosemary oil. Rosemary oil also does not contain any fatty acid chain lengths, thus meets the claim of less than C12. Note that claim 6 recites that the oil of claim 1 is inclusive of essential oils.
Scholz et al. teach skin care compositions useful in treating infection, thus meeting the intended use of the instant claims for treating skin of a patient, see paragraphs [0019] and [0376]. The composition includes an antimicrobial component comprising the antiseptic of silver colloid, see paragraph [0038], [0134], and [0190]. The colloidal silver antiseptic can be present in at least 0.20% by weight and less than 10% by weight, see paragraph [0193]. This recitation of colloidal silver overlaps and renders obvious the claimed range from 7-12% by weight. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). The composition can include one or more sugar alcohols to enhance the antimicrobial activity including xylitol present from up to 20% by weight, see paragraphs [0208] and [0244]-[0245]. The xylitol amount overlaps and renders obvious the claimed range of from 0.001-90% by weight. The antiseptic is inclusive of mixtures of antiseptics such as natural oils, see paragraph [0134]-[0135]. Natural antiseptics preferably include a mixture of tea tree oil (essential oil with no fatty acid chains) and grapefruit seed extract, see paragraph [0203] and antiseptics are added to the composition in amounts from 0.1 to 30% by weight, see paragraph [0205]. The compositions treat fungus and bacteria, see paragraph [0110]. The composition is capable of controlling biofilm, see paragraph [0268]. The composition can further include anti-inflammatory agents, excipients, lubricants, preservatives, antioxidants, flavorant or stabilizers, see paragraph [0293]. The formulation can comprise saline, see paragraph [0103]. Water can be present at up to 20% or more, see paragraph [0131]. This amount for water overlaps and renders obvious a range of 50-60% weight since 20% or more is inclusive of 20-100% by weight. The water source is inclusive of distilled water, see paragraph [0393] and furthermore purified (i.e. distilled) water is obvious to obtain a skin treatment formulation free of contaminants.
Scholz et al. does not expressly teach the inclusion of methylsulfonylmethane (MSM).
Bhushan et al. teach antimicrobial compositions for eliminating biofilm on skin which comprise methylsulfonylmethane (MSM) and EDTA, see paragraph [0002] and [0030] and [0081]. The MSM acts as an anti-inflammatory and analgesic and is present from 0.1-40% by weight, see paragraph [0093].
It would have been prima facie obvious before the effective filing date of the claimed invention to incorporate methylsulfonylmethane (MSM) as the anti-inflammatory agent of Scholz in amounts from 0.1-40% by weigh of the antimicrobial composition.
One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because Scholz et al. teach the inclusion of anti-inflammatory agents and MSM is taught to provide analgesic and anti-inflammatory properties to a skin surface. This amount overlaps and renders obvious a claimed range of 4-7% by weight of MSM. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Neither Scholz et al. nor Bhushan et al. teach the presence of rosemary oil essential oil, aloe vera and allantoin wherein the oil is 0.01-0.11 percent of the overall weight, and aloe vera is 0.001-90% by weight.
DiLeva teaches a topical composition for treating skin which includes a mixture of aloe vera, grapeseed oil, eucalyptus and rosemary oil and shea butter, see abstract and claim 1. The rosemary oil can be present from 0-40% weight per volume, and since the composition contains water as the vehicle for a carrier the rosemary can be present from 0-40% by weight, see claim 1, column 5 at line 62 and claim 6, line 5. The aloe vera can be present from 0.01-20% by weight per volume, see claim 1. Since the composition includes water as the liquid carrier the weight percent can comprise from 0.01-20% by weight. The composition treats skin conditions including microbial infections, see abstract. Aloe vera is effective in treating wounds and skin infections, see column 2 at lines 47-55. The rosemary oil provides analgesic and astringent properties, see column 3, lines 12-20. Allantoin and aloe vera provide soothing skin properties, see column 9, lines 37-33 and column 2 lines 47-55. The composition treats wounds infected with bacteria or fungus, see Examples 5 and 7.
It would have been prima facie obvious to provide the skin treating antimicrobial composition of Scholz et al. with a topical composition that comprises, rosemary oil, aloe vera and allantoin.
One of ordinary skill in the art would have been motivated to do so because DiLeva teaches skin care products with comprise rosemary, aloe vera, and allantoin help treat and heal wounds infected with bacteria or fungus. The addition of rosemary imparts analgesic properties while the addition of allantoin and aloe vera helps impart skin soothing properties to the topical product.
There would have been a reasonable expectation of success given both Scholz et al. and Di Leva teach treatment of skin infections.
Neither Scholz et al., Bhushan or DiLeva expressly teach that the topical product contains sea salt.
However, Garrett teaches skin treatment compositions which contain antiseptics, see abstract, column 7 lines 51-53 and 60 . Examples of antiseptic compounds include tea tree oil, see column 18, lines 56-58. The composition includes sea salt which is useful as a skin softener compound, see column 20 lines 14-15, and column 30 lines 17-18.
It would have been prima facie obvious to include sea salt with the topical formulations of Scholz et al. with the motivation of imparting skin softening properties to the topical product.
There would have been a reasonable expectation of success because Scholz et al. teach that the topical skin treating formulation can further include excipients, and both Scholz and Garret teach skin treating compositions which comprise antiseptic compounds.
Regarding the amount of grapefruit seed, Scholz et al. teach addition of antiseptic from 0.1-30% by weight. This amount overlaps and renders obvious the clamed range of 0.1-2% by weight. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)
Regarding the amount of rosemary oil, DiLeva teaches amounts from 0-40% by weight which overlaps the claimed range. Regarding the amount of the oils, Di Leva suggests from 0-40% by weight rosemary with Scholz teaching antiseptic can be present from 0.1-30% by weight. These amounts overlap the claimed range of oils from 0.01-0.11% by weight. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding the amount of aloe vera DiLeva teaches an amount of from 0.01-20% by weight. This amount overlaps and renders obvious the claimed amount from 0.001-90% by weight. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)Furthermore, one of ordinary skill in the art would have been motivated to adjust the concentration of aloe to the dried amount to impart healing properties to the skin as suggested by DiLeva.
Conclusion
Currently no claims are allowed and claims 1-10 and 12-18 are rejected.
Correspondence
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/SARAH ALAWADI/Primary Examiner, Art Unit 1619